Key findings:
Key findings of the abstract include identifying thrombophlebitis risk factors among patients at I.G.M.C Shimla, emphasizing male gender, Type 2 Diabetes Mellitus, alcohol consumption, smoking status, and BMI over 23 as significant independent risk factors. The study suggests controlling these factors to potentially reduce thrombophlebitis incidence.

What is known and what is new?
Thrombophlebitis, inflammation due to clot formation, exhibits identifiable clinical signs. This study at I.G.M.C Shimla identifies male gender, Type 2 Diabetes Mellitus, alcohol consumption, smoking, and BMI over 23 as significant risk factors. Chi-square tests reveal drug-use associations, implying potential interventions to mitigate thrombophlebitis incidence.

What is the implication, and what should change now?
Thrombophlebitis presents significant health risks, with identified factors including male gender, Type 2 Diabetes Mellitus, alcohol consumption, smoking, and BMI over 23. Chi-square tests highlight drug-use associations, signaling the need for targeted interventions to reduce incidence rates and improve patient outcomes in hospital settings.
 

In modern medical practice, up to 80% of the hospitalized patients receive intravenous (IV) therapy at some time  during their admission [1]. The peripheral venous catheterization is a commonly done invasive procedure to administer  medications, fluids and bio products. The most common complication associated with it is thrombophlebitis with  incidence ranging from 3.7% to a massive 67%, according to different settings [2]. Thrombophlebitis is the inflammation of  the vessel wall due to the formation of blood clots. Clinical signs of phlebitis are localized redness, warmth, swelling and  palpable venous cord . Over the last two decades, studies about phlebitis have divided the risk factors into four main  groups: patient characteristics, therapy administered, health professional practices and cannula characteristics. [3] 

The complications associated with peripheral IV cannula and IV therapy can have a devastating effect on a patient's  health and quality of life and also increase the costs of health care through prolonged hospital stay and treatment. By  knowing the risk factors for superficial thrombophlebitis, we can take measures to reduce its incidence which ultimately  will lead to decrease in morbidity and prevent prolonged hospital stay and bed occupancy at our institution. Given that  thrombophlebitis can put patient’s safety at risk, this study was aimed to identify the associated risk factors in patients  admitted in the medicine department at I.G.M.C Shimla. 
 

All adult patients admitted in Medicine wards and requiring intravenous cannulation during the period from July 2018 to June 2019 were included in this observational study conducted in Department of Medicine, Indira Gandhi Medical College (IGMC), Shimla, Himachal Pradesh.  

The patients were excluded if already suffering from thrombophlebitis at the time of admission, unconscious patients,  patients with pre-existing septicaemia, patients who were hemodynamically unstable, patients who were cannulated in  casualty, and/or patients who had already been cannulated at periphery. The study was initiated following approval from the institute ethics committee at IGMC Shimla. All the study participants were included after they agreed to participate in the study.  

Data was entered in Microsoft Excel spreadsheet and analysed using Epi Info software version 7.2.2. Categorical data were presented as the number of patients, their percentage and 95% Confidence Intervals. For quantitative variables, means and standard deviations were calculated. Chi square test was applied to determine the association between the use of different drugs and the occurrence of thrombophlebitis. A p-value of less than 0.05 was considered to be statistically significant. 
 

A total of 269 participants were included in the study, of which nearly 42% males and the rest were females  (58%). Mean age of the patients was 49.85(±17.68) years. (51.12%) patients aged <60 years and 54 (59.34%) patients  aged ≥60 years developed thrombophlebitis. The P value was 0.201. Out of 269 patients,69(62.16%) males and  76(48.10%) females developed thrombophlebitis with P value of 0.023. 

123(51.25%) non- diabetic patients and 22(75.86%) patients with diabetes mellitus developed thrombophlebitis with  P value of 0.012 which was statistically significant.  

Among patients with hypertension, 38(56.72%) patients developed thrombophlebitis with P value of 0.594 & was not  statistically significant. 45(73.77%) patients who had a history of alcohol intake developed thrombophlebitis with P value of 0.000 and  44(64.71%) patients who were smokers developed phlebitis with P value of 0.039. Both smoking and alcohol intake were  found to be a significant risk factor for thrombophlebitis. (Table 1)

BMI was also studied as a risk factor. 33(45.31%) patients with BMI within normal range(18.5-22.9) developed  thrombophlebitis and 112(58.64%) patients with BMI either >22.9 or <18.5 developed thrombophlebitis with P value of  0.015. so, abnormal BMI or obesity was also found to be a risk factor for thrombophlebitis. 

Table 1: Risk factors for Thrombophlebitis among the study participants (N=269) a

In our study, no difference in the incidence of thrombophlebitis was found in different age groups, that is age ≥60  years and age <60 years. This is in consistency with other studies, [4] where no difference was found in the incidence of  phlebitis in patients aged ≥60 years old or < 60 years old. Study conducted by Abhijit Mandal & Raghu [5], found that  the risk of developing phlebitis was more in the age group less than 60 years (34.80% Odds ratio [OR] 1.58, 95%  Confidence Interval [CI] 0.78‑ 3.19), this is comparable to study conducted by Singh et al.,[6] and Diwedi et al.,[7]  In  contrast to above findings Carballo et al.,[8] and Bregenzer et al., found out that incidence was more in age group more  than 60 years. One of the reasons quoted in literature regarding lower incidence rate in the elderly is impaired  inflammatory response. 

One of the most striking findings of our study was the relationship between diabetes mellitus and phlebitis. In diabetic  patients, phlebitis was more common than in non-diabetics. This risk factor was evaluated in a few studies. This result of  our study coincided with the result of the study conducted by Salma U et al., at Dhaka National Medical College Institute  Hospital. [9]. In this study , the incidence of thrombophlebitis in diabetes was 25% compared to 2.68% in non-diabetics. In  Monreal et al.,'s [10] study, diabetes mellitus was not a risk factor. [10]. A higher rate of phlebitis in these patients may be due to  the endothelial damage induced by diabetes mellitus, that predisposes patients to phlebitis. Good control of diabetes  mellitus, greater attention and care during insertion, and changing catheters within 72 hours may reduce the rate of  phlebitis in these patients. [11]

HTN was not associated with increased incidence of thrombophlebitis in our study. Similar results were observed in  the study conducted by Jisal Saji et al., [12]
This is in contrast to the result of the study conducted by Salma U et al., [9] at Dhaka National Medical College Institute  Hospital. In this study the incidence of thrombophlebitis in patients with HTN was 32.89% compared to 7.59%  in  patients without HTN and was statistically significant. 

In our study, alcohol was associated with greater occurrence of thrombophlebitis with p value of less than 0.001 which was statistically significant. Similarly, smoking was also found as a significant risk factor for thrombophlebitis with p value of 0.039. This is in contrast to a study conducted by Jisal Saji et al., in which smoking was not found as a significant risk factor for thrombophlebitis. Obesity was also found to be a significant risk factor for development of thrombophlebitis. 
 

Male gender, presence of Type 2 Diabetes Mellitus, Consumption of alcohol and smoking status, and the presence of BMI more than 23 were found to be strong independent risk factors for thrombophlebitis among our study participants.  Control of these factors might prove useful in reducing the incidence of Thrombophlebitis.

Funding: No funding sources.

Conflict of interest: None declared.

Ethical approval: The study was approved by the Institutional Ethics Committee of Indira Gandhi Medical College.
 

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